(189 days)
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
The Probe Covers for Thermometers, which made of PE and EVA, are used for thermometers as barriers during oral or rectal temperature measurements. The Probe Covers are suitable for varied thermometers and non-sterilized packaging. A sandwich structure which is formed by the top and back paper and middle films.
The provided text is a 510(k) Premarket Notification for "Probe Covers for Thermometers" and outlines the device's characteristics and its substantial equivalence to a predicate device. It defines the device, its intended use, and its comparison to an existing device (Yu Long Sheng Disposable Thermometer Sheath, K102508).
However, the document does not describe a study that involves an AI/ML device, expert ground truth establishment, sample sizes for training/test sets, or detailed performance metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device. Instead, it describes compliance with engineering and biocompatibility standards for a physical medical accessory.
Therefore, I cannot extract the information required to populate the table and answer the subsequent questions about an AI/ML study. The provided text is solely about the regulatory clearance of a non-AI/ML medical device accessory.
Here's why I cannot fulfill your request based on the provided text:
- No AI/ML Device: The device is "Probe Covers for Thermometers," a physical accessory. It does not involve any artificial intelligence or machine learning component.
- No Diagnostic Performance Study: The "performance" section refers to compliance with ASTM E1104-98 (Standard Specification for Clinical Probe Covers and Sheaths) and ISO 10993 (Biocompatibility). These are standards for physical properties (leakage, toxicity, compatibility) and material safety, not for diagnostic accuracy or algorithmic performance.
- No "Ground Truth" as related to AI: Ground truth in an AI/ML context typically refers to validated medical conditions (e.g., presence or absence of a disease) established by experts, pathology, or outcomes for a machine to learn from or be tested against. For a thermometer probe cover, "ground truth" relates to physical specifications and material safety.
- No Human Reader Study (MRMC): There is no mention of human readers or comparative effectiveness studies with or without AI assistance, as the device is not a diagnostic tool that assists human interpretation.
Therefore, I must state that the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets them.
If you have a document describing an AI/ML medical device and its corresponding studies, please provide that, and I would be happy to help.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 24, 2018
K-jump Health Co., Ltd. JM Lin Regulatory Affairs Representative No. 56, Wu Kung 5th Road, New Taipei Industrial Park New Taipei City, 24890 Taiwan
Re: K180714
Trade/Device Name: Probe Covers for Thermometers Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 22, 2018 Received: August 24, 2018
Dear JM Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180714
Device Name Probe Covers for Thermometers
Indications for Use (Describe)
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Number: K180714
Image /page/3/Picture/2 description: The image shows the logo for "K-jump". The logo is written in a sans-serif font and is blue. There is a circle above the "i" in "K-jump", and a horizontal line through the "K". There is a registered trademark symbol to the right of the word "jump".
This is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter information
Company Name: K-jump Health Co., Ltd.
| Address: | No. 56, Wu Kung 5th Rd. New Taipei Industrial Park, New Taipei City24890, Taiwan |
|---|---|
| Contact person: | JM Lin, Regulatory Affairs Representative |
| Phone: | +886-2-2299-1378 ext. 237 |
| Fax: | +886-2-2299-1385 |
| Email: | jm@kjump.com.tw |
| Prepared date: | March 13, 2018 |
2. Name of Device
Trade Name: Probe Covers for Thermometers Common/Usual Name: Disposable Thermometer Covers and Sheaths Regulation Number: 21 CFR 880.2910 Classification Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL
3. Predicate Device
Device Name Yu Long Sheng Disposable Thermometer Sheath (YU LONG SHENG TECHNOLOGY CO., LTD.) 510(k) Number K102508
Decision Date 01/10/2011
This predicate has not been subject to a design-related recall.
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510(k) Number: K180714
510(k) Summary
Image /page/4/Picture/2 description: The image shows the logo for "K-jump" in blue. The logo is stylized with a unique font. The "K" is large and bold, with a dot above it. The word "jump" is connected to the "K" and is also in blue. There is a registered trademark symbol to the right of the word "jump".
4. Device Description
The Probe Covers for Thermometers, which made of PE and EVA, are used for thermometers as barriers during oral or rectal temperature measurements. The Probe Covers are suitable for varied thermometers and non-sterilized packaging.
5. Indications for Use
The Probe Covers for Thermometers are intended for use as barriers between thermometers and oral cavities or users' rectum. The subject devices are used as accessories for digital thermometers and intended for single use only.
6. Comparison of technological characteristics with Predicate Device
The subject device is substantially equivalent to the predicate device, K102508, the disposable thermometer probe sheath. The comparison of their characteristics is summarized in the table below.
| Characteristics | K-JUMP HEALTH CO.,LTD.K180714 | YU LONG SHENGTECHNOLOGY CO., LTDK102508 | Indicatedifference orsimilarity |
|---|---|---|---|
| Device name | Probe Covers forThermometers | Yu Long Sheng DisposableThermometer Sheath/Model YLS-01 | difference |
| Indications forUse. | The Probe Covers forThermometers are intendedfor use as barriers betweenthermometers and oralcavities or users' rectum. Thesubject devices are used as | YLS-01 is intended for use as abarrier that is used as anaccessory to oral or rectal fordigital thermometers. Thissheath is non-sterile and isintended for single patient use | similarity |
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510(k) Summary
510(k) Number: K180714
Image /page/5/Picture/2 description: The image shows the logo for K-Jump. The logo is written in a blue, sans-serif font. The "K" is stylized with a dot above it and a line through the middle. The word "jump" is written in lowercase letters and is connected to the "K". There is a registered trademark symbol to the right of the word "jump".
| Characteristics | K-JUMP HEALTH CO.,LTD.K180714 | YU LONG SHENGTECHNOLOGY CO., LTDK102508 | Indicatedifference orsimilarity |
|---|---|---|---|
| accessories for digitalthermometers and intendedfor single use only | only | ||
| Structure | A sandwich structure whichis formed by the top andback paper and middle films. | A sandwich structure whichis formed by the top andback paper and middle films. | similarity |
| Dimensions | 92 x 25 mm | 94 x 26 mm | difference |
| Materials | EVA film | EVA film | similarity |
| Use type | Single use | Single use | similarity |
| Sterile package | Non-sterilized | Non-sterilized | similarity |
| Performance | Comply with ASTM E1104 | Comply with ASTM E1104 | similarity |
| Biocompatibility | Comply with ISO 10993-5and ISO10993-10 | Comply with ISO 10993-5and ISO10993-10 | similarity |
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Discussion of Main Differences:
Both the subject device and predicate device have the similar intended use, same materials and structures. The only minor difference are the dimension and appearance. The subject device is substantial equivalent to the predicate device according to both of them are complied with the same performance standards.
7. Performance Summary
The performance of the Probe Covers for Thermometers is verified and validated to comply with following recognized standards and does not raise any performance issues.
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- Performance
ASTM E1104-98 (Reapproved 2016) Standard Specification for Clinical Probe Covers and Sheaths
- Performance
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510(k) Summary
510(k) Number: K180714
Image /page/6/Picture/2 description: The image shows the logo for K-jump. The logo is in blue and features a stylized "K" with a dot above it, followed by the word "jump" in a cursive font. A registered trademark symbol is located to the right of the word "jump".
The subject device complies with ASTM E1104-98 requirements including general requirements, toxicity test, leakage test, compatibility test and storage environment test.
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- Biocompatibility:
ISO 10993-5 Third Edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- Biocompatibility:
The subject device complies with applicable biocompatibility requirements and the device meets the endpoints for cytotoxicity, sensitization & irritation-negligible.
8. Conclusions
The Probe Covers for Thermometers have the similar intended use, materials and technological characteristics with the predicate device. Moreover, both devices comply with same performance standards. All information described above can demonstrate the subject device is substantial equivalent to the predicate device.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.